Mar 21, 2017  |  Posted by: 

Paperless Validation Paperless validation systems were introduced to the industry 10 years ago. Early in the lifecycle of these technology paperless validation system provided standard document management and electronic execution capabilities. This basic funct...  
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Mar 13, 2017  |  Posted by: 

Data Integrity by Design is Your First Line of Defense!

If you’ve had your finger anywhere near the regulatory pulse, then you know Data Integrity is on the regulatory radar. Some turn to statistics to assess data to identify anomalies. Others rely on Validation to ensure a system is performing as intended. Consider the following illustration that identifies three (3) major aspects of the Data Integrity paradigm.



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Feb 24, 2017  |  Posted by: 

Cleaning Validation Validation and calibration are a global regulatory requirement for the life science industry. Validation is defined by the FDA as a process that is required to establish documented evidence which provides a high degree of assurance that a spec...  
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Feb 16, 2017  |  Posted by: 

Writing requirements using must, shall, should statement qualifiers can significantly help you manage and deliver a system that is compliant, fully functional, and maybe even include some nice-to-haves.

Characteristics of a Good Requirement:

Apparatus used to conduct the required process or test.

Instrument:

But first let’s review what characterizes a good requirement statement. The Institute of Electrical and Electronics Engine...  
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Feb 06, 2017  |  Posted by: 

Cleaning Validation Electronic systems were introduced in the industry over 35 years ago. Early in the lifecycle, electronic systems enabled companies to partially automate document management, change control, data acquisition and deviation processes. Unfortunately, these ...  
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Jan 31, 2017  |  Posted by: 

Cleaning Validation Cleaning validation is a global regulatory requirement for the life science industry. The purpose of cleaning validation is to establish documented evidence with a high degree of assurance that the cleaning process will consisten...  
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Jan 25, 2017  |  Posted by: 

Much has been written about validating equipment, instruments, and computer systems. Add articles written about 21 CFR Part 11 to the pile and you become engulfed in a titlewave of information. But one thing that’s often overlooked is the need to define key terms first, and then assign responsibility based upon a clear understanding of the terms you’ve just defined.
Validation is more effective when you first define the things you’re v...  
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Jan 06, 2017  |  Posted by: 

Data integrity has become a very hot topic in recent years in the regulated industry. Several data integrity guidance documents have been published by FDA and MHRA. These documents describe the regulatory agencies current expectations related to data integrity. There is a significant amount of confusion and misunderstanding of what data integrity requirements mean to the industry. Data integrity is not a new challenge for the industry. Data integrit...  
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